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Where the GvP (for the EU) and specific legislation in other territories refers to “the quality processes”, they are referring to Standard Operating Procedures (SOPs). These fit into the overall information structure of the company like this:
SOPs are the quality control documents which implement company policy. Working practice documents are then derived from the SOPs to provide detailed guidance to staff in the execution of the tasks outlined in the SOPs. For those working within a pharmacovigilance system, training on SOPS would also be expected as well.
The implementation of SOPs is audited, inspected and regulated by the competent authorities in accordance with Quality Management Guidelines contained in the EMA’s GvP. Your SOPs are therefore a pivotal component of your drug safety system.
Generic Templates Alone Are Not Adequate
SOPs are always product and company specific. Your overall company policy will clearly be the driving agent dictating the nature of these documents for individual medicinal products / marketing authorisations. It is not appropriate to use a generic template because each pharmaceutical company is different, each marketing authorisation is different and each product is different. If your company working practices are going to be specific for your company, they cannot be derived from “generic” SOPs.
Standard generic templates are therefore inadequate without proper advice and modification. In order to comply with EU pharmacovigilance laws, each Standard Operating Procedures document must be:
- Extremely detailed
- Written using the correct terminology
- Of an adequate length (possibly extending to some 20 or 30 pages)
- Reflective of your specific company structures and practices
In order to put together a set of compliant SOPs you need a highly experienced, responsive and flexible pharmacovigilance service provider for advice on cost effective compliance. For example, whilst 2 or 3 SOPS could adequately describe an entire pharmacovigilance process for one product in one company, other systems elsewhere could require more than a dozen.
Why Choose PrimeVigilance To Help Write Your SOP?
Our consultants have written compliant SOPs for many years for a highly diverse range of companies and medicinal products and processes. No matter what size and shape of company, your SOPs are all controlled, comprehensive and specific:
- Each SOP release must be controlled and numbered
- All document circulation and distribution must be accurately controlled
- Versioning must allow for vital comparisons and control of modifications at every stage
- The SOPs must be kept up to date and must be current, specifying current practice rather than reflecting obsolete procedures which are no longer used or no longer valid or compliant.
- All activities and processes carried out by the company most be covered by an SOP. They have to be checked to ensure that they are comprehensive and that there are no “process gaps” – areas of activity not covered by an SOP.
- Responsibilities must be allocated to named personnel
- Timescales must be clearly established
- Regular review and progress monitoring is essential
- Compliant and timely documentation of this review and monitoring is essential
- Documentation must be accompanied by flowcharts
- There must be cross-reference made to other SOPs wherever appropriate
Your SOP can be seen as the broader description of activities and processes. Then your pharmacovigilance Working Practice Documents are the vital fine detail which consistently explains everything you do. They must:
- Detail every facet of the work to be undertaken, in minute, precise and step by step detail
- Be accompanied by screenshots and instructions where appropriate
We recommend expert advice at every step of your SOP journey. The process of creating and reviewing SOPs is ongoing: drafting, reviewing, approving, training, implementation and periodic review are all part of the overall process. They are audited and inspected as part of a pharmacovigilance system. To find out more about our cost effective, complaint and controlled Standard Operating Procedures writing services, simply call in confidence on +44 (0)1483 307920.
1. EMA. 2012. Guideline On Good Pharmacovigilance Practices (GVP) Module II. Available at: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500129133 [Accessed 01 September 2012]